An interventional study of Web-based care management and Telephone and face-to-face care management in Diabetes Mellitus and Hypertension, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 25 Years to 79 Years. Per ClinicalTrials.gov, last updated 2015-04-07.
Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment
This study is comparing the effectiveness of web-based care management to either telephone-based care management or internet access alone, in patients with poorly controlled diabetes mellitus.
Background:
Patients with diabetes and elevated hemoglobin A1c (HbA1c) are at risk for diabetes-related complications. Care-management may be helpful in these patients, by providing direct contact between such high-risk patients and the healthcare system. Web-based systems have previously shown promise as a means of neutralizing access barriers such as scheduling and travel to appointments and may be of particular help in improving diabetes care.
Objectives:
We examined the efficacy of two methods of diabetes education and care management: (1) a traditional model that involved telephone contact and face-to-face encounters (2) a web-based model with access to a diabetes care management web site. We compared these interventions to a study group that received no education or care management but was provided with a computer and access to diabetes self-management websites.
Methods:
This study employed a randomized, parallel group design involving patients with diabetes mellitus and an elevated HbA1c ( 8.5%). Participants assigned to web-based care management received a notebook computer, Internet access and interacted with a care manager through a diabetes education and care management website. Participants receiving telephone-based care management interacted with a care manager using telephone and face-to-face contact. Both care management models employed medication algorithms to improve glucose and BP control. These care management groups were compared to a study group that had no care management but received a notebook computer and Internet access with their "home page" containing links to a series of diabetes self-management websites (i.e. computer only group). The primary outcome measures were HbA1c, blood pressure, and scores on the Problem Areas in Diabetes (PAID) questionnaire, each measured over 12-months.
Status:
Complete
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 152 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Intervention group
Procedure: Web-based care management
Comparator
Procedure: Telephone and face-to-face care management
Comparator
Procedure: Internet access alone
Participants interact with a care manager, sending and receiving messages using an internet portal that accepts uploads from glucose and BP meters
Participants interact with a care manager via face-to-face and telephone contact
Participants are given internet access and encouraged to seek diabetes information to help in their self management
Change in HbA1c at 12 months
Time frame: 12 months
Change in blood pressure, lipid profile and diabetes-related stress (self-report) at 12 months; cost-effectiveness analysis of the interventions.
Time frame: 12 months
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs →